Section 338.489. Automated devices.

(1) An automated device means a device designed for the specific purpose of selling, dispensing, or otherwise disposing of  any  drug or  device ordered by a prescription.

(2)  An automated device may be used only in the following locations:

(a)   A pharmacy.

(b)   A hospital.

(c)   A county medical care facility.

(d)  A hospice.

(e)   A nursing home.

(f)  Other skilled nursing facility as defined in 1978 PA 368, MCL 333.20109.

(g)   An office of a dispensing prescriber.

(3)   An automated device designed for  the   specific  purpose  of selling, dispensing, or otherwise disposing  of  any  drug  or  device ordered  by  a prescription, as defined in the code, and located within a licensed pharmacy shall be used only by a pharmacist or   other    pharmacy personnel  under   the personal charge of a pharmacist.

(4)     If an automated dispensing device is  used  in  a  dispensing prescriber's office, the device shall be used only to dispense medications to the dispensing prescriber's patients and only under the control of the dispensing prescriber. A pharmacy shall not own, control, or operate an automatic dispensing device in a dispensing prescriber's office.

(a)    If a dispensing prescriber delegates the stocking of the device, then technologies shall be in place and utilized to ensure that the correct drugs are stocked in their appropriate assignment utilizing a board-approved error prevention technology that complies with R 338.3154.

(b)   A dispensing prescriber operating an automated device is responsible for all medications that are stocked and stored in that device as well as removed from that device.

(c)    If any medication or device is dispensed from an automated device, then documentation as to the type of equipment, serial numbers, content,  policies, procedures, and location within the facility shall be maintained by the dispensing prescriber for review by an agent of the board. This documentation shall include at least  all  of the following information:

(i)   Manufacturer name and model.

(ii)         Quality    assurance     policy      and     procedure      to       determine continued appropriate use and performance of the automated device.

(iii)   Policy and procedures  for   system  operation   that  addresses   at  a minimum all of the following:

(A)  Accuracy.

(B)  Patient confidentiality.

(C)  Access.

(D)  Data retention or archival records.

(E)  Downtime procedures.

(F)   Emergency procedures.

(G)  Medication security.

(H)  Quality assurance.

(5)   An automated device that is  to  be   used  for  the  furnishing  of medications for administration to registered patients in any hospital, county medical care facility, nursing home, hospice, or any other skilled nursing facility, as defined in 1978  PA 368, MCL 333.20109, shall be supplied and controlled by a pharmacy that is licensed and located in this state. The use of an automated device in these locations is not limited to the provisions of subrule (3) of this rule. If a pharmacist delegates the stocking of the device, then technologies shall be in place and utilized to ensure that the correct drugs are stocked in their appropriate assignment utilizing  a  board- approved error prevention technology that complies with R 338.3154.Each such device shall comply with all of the following provisions:

(a)    A pharmacy operating an automated   device  is  responsible  for all medications that are stocked and stored in that device as well as removed from that device.

(b)    If any medication or device is dispensed from an automated device, then documentation as to the type of equipment, serial  numbers,  content,  policies, procedures,   and  location  within the   facility   shall  be maintained  by  the pharmacy for review by an agent  of  the   board.  The documentation  shall include at least all of the following information:

(i)    Name and address of the pharmacy responsible for the      operation       of the automated device.

(ii)   Name and address of the facility where the device is located.

(iii)   Manufacturer name and model number.

(iv)         Quality    assurance     policy     and    procedure    to    determine       continued appropriate use and performance of the automated device.

(v)   Policy and procedures for system operation that address  at   a  minimum all of the following:

(A)  Accuracy.

(B)  Patient confidentiality.

(C)  Access.

(D)  Data retention or archival records.

(E)  Downtime procedures.

(F)   Emergency procedures.

(G)  Medication security.

(H)  Quality assurance.

(I)  Ability to provide on demand to an agent of the board a list of medications qualifying for emergency dose removal without pharmacist prior review of the prescription or medication order.

(6)   Records and electronic data kept by automated devices shall meet all of the following requirements:

(a)   All events involving access  to  the  contents  of   the   automated devices shall be recorded electronically.

(b)    Records shall be maintained for 5 years by the pharmacy and shall be retrievable on demand for review by an agent of the board. The  records shall include all of the following information:

(i)   The unique identity of device accessed.

(ii)   Identification of the individual accessing the device.

(iii)   The type of transaction.

(iv)   The name, strength, dosage form and quantity of the drug accessed.

(v)   The name of the patient for whom the drug was ordered.

(vi)     Identification of the pharmacist responsible for the  accuracy   of  the medications to be stocked or restocked in the device.

(7)   Policy and procedures for the use of the automated device shall include a requirement for pharmacist review of the prescription or medication order before system profiling or removal of any medication from the system for immediate patient administration.   This subrule does not apply to the following situations:

(a)   The system is being used as an  after-hours   cabinet  for medication dispensing in the absence of a pharmacist as provided  in R 338.486(4)(i).

(b)     The system is being used in place of an emergency kit as provided in R 338.486(4)(c).

(c)    The system is being accessed to remove medication required to treat the emergent needs of a patient as provided in R 338.486(4)(c). A sufficient quantity to meet the emergent needs of the patient  may  be removed  until  a pharmacist is available to review the medication order.

(d)   In each of the situations specified in subdivisions (a) to (c) of this subrule, a pharmacist shall review the orders and authorize any further dispensing within 48 hours.

(e)   The device is located in a dispensing prescriber's office.

(8)   A copy of all policies and procedures related to the use of an automated device shall be maintained at the pharmacy responsible for the device's specific location or at the dispensing prescriber's office and be available for review by an agent of the board.

History: 1979 AC; 1980 AACS; 2007 AACS.